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Arterial chemo combo shows promise in stomach cancer trial

NCT ID NCT05593458

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether giving chemotherapy directly into the artery (instead of through a vein) along with immunotherapy can better shrink locally advanced stomach cancer before surgery. About 190 participants will receive either the standard chemo regimen or the arterial infusion approach, followed by surgery and additional treatment. The study aims to see if the new method leads to higher rates of tumor clearance and better long-term survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Oxaliplatin, S-1, and Sintilimab (PD-1 antibody)
What this could lead to
If this works, it could offer a more effective way to shrink gastric tumors before surgery, potentially improving survival and reducing recurrence.
What could go wrong
This is a mid-stage trial with only 190 participants, so results may not apply to everyone. Arterial infusion carries risks like bleeding or infection, and the added benefit over standard therapy is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 190 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Eastern Cooperative Oncology Group(ECOG) score 0-1 * Ambulatory males or females, aged 18-75 years * Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II or III) * Locally advanced gastric carcinoma (cT3N2-3M0, cT4aN1-3M0, cT4bNanyM0, American Joint Committee on Cancer (AJCC) TNM staging system 8th edition) * Life expectancy more than 3 months * Give written informed consent, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. * Normal hepatic, renal, and bone marrow function (ALT/AST\<2.5 fold of upper limit value;Tbil\<1.5mg/dl, Cr\<1.5 fold of upper limit value; White Blood Cell count≥3 × 10\^9/L, ANC ≥ 1.5 × 10\^9/L,PLT≥ 80 × 10\^9/L,Hb ≥ 90 g/L). Exclusion Criteria: * Patients can not bear surgical procedure. * Pregnant or lactating women. * HER2 overexpression(+++) confirmed by immunohistochemistry. * Previous cytotoxic chemotherapy, radiotherapy or immunotherapy. * History of another malignancy within the last five years. * History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake. * Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months. * History of dysphagia, complete or partial gastrointestinal obstruction, active gastrointestinal bleeding and gastrointestinal perforation; * Organ allografts requiring immunosuppressive therapy. * Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease. * Moderate or severe renal impairment: serum creatinine \> 1.5 x upper limit of normal (ULN). * Hypersensitivity to any drug of the study regimen. * With abdominal cavity implantation metastasis or distant metastasis. * Unwilling or unable to comply with the protocol for the duration of the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

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